Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

K200983 · Ningbo Hesi Electric Co., Ltd. · OHS · Jul 14, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K200983
• Device Name: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine
• Applicant: Ningbo Hesi Electric Co., Ltd.
• Product Code: OHS · General, Plastic Surgery
• Decision Date: Jul 14, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles. The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles - The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Device Story

Wearable LED phototherapy devices (mask HK207; flexible panel HK209) for home use; intended for aesthetic and therapeutic applications. Devices emit specific light wavelengths: blue (465nm) for acne; red (640nm) and infrared (880nm) for wrinkle reduction; infrared for topical heating. User-operated by adults; devices fit anatomical contours using biocompatible materials. Output consists of light energy and heat; intended to elevate tissue temperature, promote muscle relaxation, and increase local blood circulation. Clinical decision-making is patient-driven based on aesthetic or minor pain relief needs. Benefits include non-invasive management of acne, wrinkle appearance, and temporary pain relief.

Clinical Evidence

No clinical data. Bench testing only, including biocompatibility (ISO 10993-5, ISO 10993-10) and electrical safety/EMC (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57).

Technological Characteristics

Wearable LED phototherapy device; biocompatible materials; wavelengths 465nm, 640nm, 880nm; irradiance 6.5 mW/cm²; dose 11.7 J/cm²; power input 100–240Vac, 50/60Hz. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-57.

Indications for Use

Indicated for adults with mild to moderate inflammatory acne vulgaris (blue light), full-face wrinkles (red/infrared light), and for topical heating to relieve minor muscle/joint pain, arthritis, muscle spasm, stiffness, and to increase local blood circulation (infrared light).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

• BioPhotas Celluma³ (K152280)
• BioPhotas Celluma³ (K171323)

Submission Summary (Full Text)

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July 14, 2021

Ningbo Hesi Electric Co., Ltd Ms. Cassie Lee Guangzhou GLOOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong 511495 China

Re: K200983

Trade/Device Name: LED facial light therapy mask (Model: HK207), Flexible LED light therapy (Model: HK209) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHS, OLP, ILY Dated: April 2, 2020 Received: April 14, 2020

Dear Cassie Lee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200983

#### Device Name

LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209)

Indications for Use (Describe)

The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to:

- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face writtles.

The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to:

- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles

- The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stifficess; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

# 510(k) Summary of K200983

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

# 1. Submitter's Information

Sponsor Name: NINGBO HESI ELECTRIC CO., LTD Establishment Registration Number: 3009784099 Address: NO.818-23-156 Qiming Rd, Yinzhou, Ningbo City Zhejiang, CHINA Postal code: 315000 Contact name: MA LULU (General Manager) Tel: [phone] Fax: [phone] E-mail: [e-mail]

## 2. Date of the summary prepared: July 13, 2021

### 3. Application Correspondent:

Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: [phone] Email: [e-mail]

# 4. Subject Device Information

Type of 510(k): Traditional Classification Name: Light Based Over-The Counter Wrinkle Reduction (OHS); Over-The-Counter Powered Light Based Laser For Acne (OLP); Lamp, Infrared, Therapeutic Heating (ILY) Trade Name: LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209) Review Panel: General & Plastic Surgery Product Code: OHS, OLP, ILY

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

Regulation Number: 890.5500, 878.4810 Regulatory Class: II

### 5. Predicate Device Information

| Sponsor | Biophotas, Inc | Biophotas, Inc |
|-----------------------|--------------------|--------------------|
| Device Name and Model | BioPhotas Celluma³ | BioPhotas Celluma³ |
| 510(k) Number | K152280 | K171323 |
| Product Code | ILY, OHS, OLP | OHS |
| Regulation Number | 890.5500, 878.4810 | 878.4810 |
| Regulation Class | II | II |

# 6. Device Description

LED FACIAL LIGHT THERAPY MASK (Model: HK207) is a home use wearable LED phototherapy device designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. The red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.

FLEXIBLE LED LIGHT THERAPY (Model: HK209) is a highly shapeable LED panel designed to fit the contours of the target areas of the anatomy, covered with a biocompatible material, which uses specific wavelengths of light to manage aesthetic conditions. This device produces light in the near-infrared region of the spectrum (880nm) intended to provide topical heating to temporary pain relief. Blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) in combination with infrared light (880nm) is intended to improve the appearance of wrinkles.

### 7. Intended Use / Indications for Use

The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to:

- The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- -The device emitting enerqy in the red and infrared spectrum is intended for the treatment of full-face wrinkles.

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to:

- -The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris.
- The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles
- The device is intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

### 8. Comparison to predicate device

Compare with predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material, and the applicable standards. The differences between subject devices and predicate devices do not raise new questions of safety or effectiveness.

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|--------------|
| Company | Ningbo Hesi Electronic<br>Co., Ltd | Biophotas, Inc | Biophotas, Inc | -- |
| Trade Name | LED FACIAL LIGHT<br>THERAPY MASK<br>(Model: HK207),<br>FLEXIBLE LED LIGHT<br>THERAPY (Model:<br>HK209) | BioPhotas Celluma3 | BioPhotas Celluma3 | -- |
| 510(k) Number | K200983 | K152280 | K171323 | -- |
| Product Code | OHS, OLP, ILY | ILY, OHS, OLP | OHS | SE |
| Intended Use /<br>Indications for Use | The LED FACIAL<br>LIGHT THERAPY<br>MASK (Model: HK207)<br>is intended to:<br>- The device<br>emitting energy in | The BioPhotas Celluma3<br>is intended to deliver<br>heat in the IR spectrum<br>to provide topical<br>heating for the purpose<br>of elevating tissue | The BioPhotas<br>Celluma3<br>is intended to emit<br>energy in the visible<br>and<br>infrared region of | SE<br>Note 1 |
| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
| | the blue is<br>intended to reduce<br>the mild to<br>moderate<br>inflammatory acne<br>vulgaris. | temperature; for the<br>temporary relief of minor<br>muscle and joint pain,<br>arthritis and muscle<br>spasm; relieving<br>stiffness; promoting the<br>relaxation of muscle<br>tissue; and to<br>temporarily increase<br>local blood circulation. | the<br>spectrum for use in<br>the<br>treatment of full face<br>wrinkles. | |
| | - The device<br>emitting energy in<br>the red and<br>infrared spectrum<br>is intended for the<br>treatment of full-<br>face wrinkles.<br>The FLEXIBLE LED<br>LIGHT THERAPY<br>(Model: HK209) is<br>intended to: | The blue spectrum light<br>is intended to<br>reduce mild to moderate<br>inflammatory acne<br>vulgaris. The Celluma³<br>is intended to emit<br>energy in the red and<br>infrared spectrum for<br>use in dermatology for<br>the treatment of<br>periorbital wrinkles. | | |
| | - The device<br>emitting energy in<br>the blue is<br>intended to reduce<br>the mild to<br>moderate<br>inflammatory acne<br>vulgaris. | | | |
| | - The device<br>emitting energy in<br>the red and<br>infrared spectrum<br>is intended for the<br>treatment of full- | | | |

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Sponsor:

Subject Device:

Document Name: K number:

NINGBO HESI ELECTRIC CO., LTD LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209) 510(k) Summary K200983

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------|
| | face wrinkles<br>- The device is<br>intended to deliver<br>heat in the IR<br>spectrum to<br>provide topical<br>heating for the<br>purpose of<br>elevating tissue<br>temperature; for<br>the temporary<br>relief of minor<br>muscle and joint<br>pain, arthritis and<br>muscle spasm;<br>relieving stiffness;<br>promoting the<br>relaxation of<br>muscle tissue; and<br>to temporarily<br>increase local<br>blood circulation. | | | |
| Regulation<br>Number | 890.5500, 878.4810 | 890.5500, 878.4810 | 878.4810 | SE |
| Regulation Name | Light Based Over-The<br>Counter Wrinkle<br>Reduction (OHS); Over<br>-The-Counter Powered<br>Light Based Laser For<br>Acne (OLP); Lamp,<br>Infrared, Therapeutic | Light Based Over-The<br>Counter Wrinkle<br>Reduction (OHS); Over-<br>The-Counter Powered<br>Light Based Laser For<br>Acne (OLP); Lamp,<br>Infrared, Therapeutic | Light Based Over –<br>The Counter<br>Wrinkle Reduction<br>(OHS) | SE |

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

| Elements of<br>Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Verdict |
|-------------------------------------------------------------|-----------------------------------------------------------|------------------------------------------|-------------------------------------------------------|--------------|
| | Heating (ILY) | Heating (ILY) | Heating (ILY) | |
| Regulatory Class | Class II | Class II | Class II | SE |
| Treatment areas | Entire Face and body | Entire Face and body | Whole Face | SE<br>Note 3 |
| Intended<br>population | Adult | Adult | Adult | SE |
| Power Source(s) | Input: 100 – 240Vac,<br>2.0 A, 50/60Hz | 110 – 120V | 110-120V | SE<br>Note 2 |
| Wavelength(s)(nm) | 465nm, 640nm, 880nm | 465nm, 640nm, 880nm | Red: 640nm±25nm<br>NIR: 880nm±50nm | SE |
| Irradiances<br>(mW/cm²) | 6.5 mW/cm² | 6.5 mW/cm² | 6.5 mW/cm² | SE |
| Treatment Dose<br>(J/cm²) | 11.7 J/cm² | 11.7 J/cm² | 11.7 J/cm² | SE |
| Treatment time | 3 times a week for 30<br>min.<br>4 weeks | 3 times a week for 30<br>min.<br>4 weeks | 3 treatments per<br>week<br>(1800 seconds)<br>4 weeks | SE |
| The distance<br>between the LEDs<br>to treatment<br>surface | For model: HK207 0.5-<br>3cm<br>For model: HK209 10<br>cm | As closed to the skin | As closed to the skin | SE |
| Irradiation area | HK207: 510 cm²<br>HK209: 890 cm² | 820 cm² | 15" x 8" | SE<br>Note 3 |
| Electrical safety | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | IEC 60601-1<br>IEC 60601-1-2 | SE |

# Comparison in Detail(s):

Note 1:

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

Although the Intended Use is slightly different from the predicate devices in the description, we can find that the subject device emits the same wavelengths and the same intended purpose as the predicate device. So, the slight differences will not raise any safety or effectiveness issues.

### Note 2:

Although the "Power Source(s)" of the subject device is a little different from the predicate devices, they are all compliant with IEC 60601-2-57 requirements and the range of power source can be safely used in the USA area. So, the differences will not raise any safety or effectiveness issues.

### Note 3:

Although the "Treatment area" is a little different from the predicate devices, it's just the factor depends on the shape of the product which will not affect the safety and effectiveness, and they all compliant with IEC 60601-2-57 requirements. So, the differences will not raise any safety or effectiveness issues.

### 9. Test Summary

1) Bench test:

The LED FACIAL LIGHT THERAPY MASK (Model: HK207) and FLEXIBLE LED LIGHT THERAPY (Model: HK209) have been evaluated the safety and performance by lab bench testing as following:

- � ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity. (Biocompatibility).
- � ISO 10993-10 2010, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization. (Biocompatibility).
- � IEC 60601-1: 2005+A1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance .
- � IEC 60601-1-2: 2014-02, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - collateral standard: Electromagnetic Compatibility.
- � IEC 60601-1-11 (Edition2.0): 2015-01, Medical electrical equipment -- part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- � IEC 60601-2-57 (First Edition): 2011 for use in conjunction with IEC 60601-1:2005, Medical electrical equipment - Part 2: Particular requirements for the basic safety and essential performance of non-

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| Sponsor: | NINGBO HESI ELECTRIC CO., LTD |
|-----------------|--------------------------------------------------------------------------------------------|
| Subject Device: | LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT<br>THERAPY (Model: HK209) |
| Document Name: | 510(k) Summary |
| K number: | K200983 |

laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

2) Clinic test

N/A

# 10. Conclusion:

The subject device K200983 "LED FACIAL LIGHT THERAPY MASK (Model: HK207), FLEXIBLE LED LIGHT THERAPY (Model: HK209)" is Substantial Equivalent to the predicate devices K152280 and K171323.